A Cross-Sectional Study of Serum Levels of Adipocytokines in Children With Febrile Seizures

Sponsor

Sohag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04967066

Collaborator

(none)

Enrollment

Location

8.2

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Febrile seizure (FS) is a common neurological condition in children, affecting 2 - 14% of children. FS is defined as seizures occurring in a child aged from six months to five years that is accompanied by a fever (≥38°C) without central nervous system infection. FS is classified into simple febrile seizure (SFS) and complex febrile seizure (CFS). SFS accounts for 70-75% of FS cases and is characterized by being generalized, duration of less than 15 minutes, occurs once in 24 hours, and no previous neurologic problems. We aim to investigate serum levels of adipocytokines, specifically leptin, adiponectin, and IL-6, in children with FS.

Condition or Disease	Intervention/Treatment	Phase
Febrile Seizure	Diagnostic Test: Serum Levels of Adipocytokines

Detailed Description

The study will include three groups of children (100 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3). Children included in this study will undergo:

Thorough medical history taking: including age, gender, and seizure details for children with febrile seizures (e.g., type, duration, recurrence).
Physical examination: including vital signs (particularly temperature) and comprehensive neurological examination).
Laboratory investigations:
Routine investigations: complete blood count, C-reactive protein, blood glucose, serum electrolytes (sodium, potassium, calcium, and magnesium), liver and kidney function tests.
Serum leptin, adiponectin, and IL6: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin, adiponectin, and IL6 will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Serum Levels of Adipocytokines in Children With Febrile Seizures: A Cross-Sectional Study at Sohag University Hospital

Actual Study Start Date :

Aug 23, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
children with febrile convulsions Inclusion criteria Age from 6 months to 6 years. Seizures. Fever (≥38°C). Exclusion criteria Central nervous system infection. Epilepsy. Previous neurological abnormalities. Inborn errors of metabolism. Immunological diseases. Endocrinal diseases (e.g., diabetes mellitus). Obesity. Eating disorders. Gastrointestinal disorders (e.g., diarrhea).	Diagnostic Test: Serum Levels of Adipocytokines Serum leptin, adiponectin, and IL6: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin, adiponectin, and IL6 will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.
Febrile children without convulsions Inclusion criteria Age from 6 months to 6 years. Fever (≥38°C) due to acute infection. Exclusion criteria Seizures. Central nervous system infection. Previous neurological abnormalities. Inborn errors of metabolism. Immunological diseases. Endocrinal diseases (e.g., diabetes mellitus). Obesity. Eating disorders. Gastrointestinal disorders (e.g., diarrhea).	Diagnostic Test: Serum Levels of Adipocytokines Serum leptin, adiponectin, and IL6: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin, adiponectin, and IL6 will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.
Healthy control children Inclusion criteria Age from 6 months to 6 years. Presented for routine check-up. Exclusion criteria Fever. Seizures. Central nervous system infection. Previous neurological abnormalities. Inborn errors of metabolism. Immunological diseases. Endocrinal diseases (e.g., diabetes mellitus). Obesity. Eating disorders. Gastrointestinal disorders (e.g., diarrhea). Any illness in the last month.	Diagnostic Test: Serum Levels of Adipocytokines Serum leptin, adiponectin, and IL6: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin, adiponectin, and IL6 will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

Arm

Intervention/Treatment

children with febrile convulsions

Inclusion criteria Age from 6 months to 6 years. Seizures. Fever (≥38°C). Exclusion criteria Central nervous system infection. Epilepsy. Previous neurological abnormalities. Inborn errors of metabolism. Immunological diseases. Endocrinal diseases (e.g., diabetes mellitus). Obesity. Eating disorders. Gastrointestinal disorders (e.g., diarrhea).

Diagnostic Test: Serum Levels of Adipocytokines

Serum leptin, adiponectin, and IL6: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin, adiponectin, and IL6 will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

Febrile children without convulsions

Inclusion criteria Age from 6 months to 6 years. Fever (≥38°C) due to acute infection. Exclusion criteria Seizures. Central nervous system infection. Previous neurological abnormalities. Inborn errors of metabolism. Immunological diseases. Endocrinal diseases (e.g., diabetes mellitus). Obesity. Eating disorders. Gastrointestinal disorders (e.g., diarrhea).

Diagnostic Test: Serum Levels of Adipocytokines

Healthy control children

Inclusion criteria Age from 6 months to 6 years. Presented for routine check-up. Exclusion criteria Fever. Seizures. Central nervous system infection. Previous neurological abnormalities. Inborn errors of metabolism. Immunological diseases. Endocrinal diseases (e.g., diabetes mellitus). Obesity. Eating disorders. Gastrointestinal disorders (e.g., diarrhea). Any illness in the last month.

Diagnostic Test: Serum Levels of Adipocytokines

Outcome Measures

Primary Outcome Measures

Serum leptin [within 3 hours of seizures]
venous blood samples (3 ml) will be obtained from children with FS as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.
Serum adiponectin [within 3 hours of seizures]
venous blood samples (3 ml) will be obtained from children with FS as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum adiponectin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.
Serum IL6 [within 3 hours of seizures]
venous blood samples (3 ml) will be obtained from children with FS as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum IL6 will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age from 6 months to 6 years.
Seizures.
Fever (≥38°C) due to acute infection.
Presented for routine check-up.

Exclusion Criteria:

Central nervous system infection.
Epilepsy.
Previous neurological abnormalities.
Inborn errors of metabolism.
Immunological diseases.
Endocrinal diseases (e.g., diabetes mellitus).
Obesity.
Eating disorders.
Gastrointestinal disorders (e.g., diarrhea).
Seizures.
Previous neurological abnormalities
Any illness in the last month

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University Hospitals	Sohag		Egypt	82524

Sponsors and Collaborators

Sohag University

Investigators

Study Director: Abdelrahim A. Sadek, Professor, Sohag University
Study Chair: Abdelhady R. Abdel-Gawad, Lecturer, Sohag University
Study Chair: Elsayed M. Abdelkreem, Lecturer, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hagar Abdelhamid Mohamed, Resident of Pediatrics, Sohag University Hospital, Sohag University

ClinicalTrials.gov Identifier:

NCT04967066

Other Study ID Numbers:

Soh-Med-21-07-06

First Posted:

Jul 19, 2021

Last Update Posted:

Aug 26, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021